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We are the official Turkey office of OMC MEDICAL, one of the well-established companies in the UK.

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ARE YOU READY FOR THE MDR – IVDR PROCESS?

As of May 26, 2021, a brand new era has begun!

What you should do

CE PRODUCT CERTIFICATION

Let’s prepare your technical files, make your system applicable and have a smooth audit experience together.

Need to know

ISO 13485:2016

Medical Quality Management System

International Medical Product Certification and Audit Experience

MDR / IVDR: IMPORTER & DISTRIBUTOR

If you are an Importer and Distributor, What you will encounter in the MDR & IVDR Process

Get Information for what you need to do

and more

ISO 13485 Consulting for Medical Devices

Companies producing Medical Devices should appoint an experienced ISO 13485 Consultant…

Risk Management

Let’s review the background of ISO 14971. As a medical device manufacturer, the first thing you need to do…

Preparation of CE Technical File

The MDR 2017 / 745 Annex II Medical Device Technical File is a clear, well-organized, easily searchable…

Internal Audits, Supplier Audits

We provide audit expertise that can more effectively drive change and improvements. Your internal audit…

Medical Device Single Audit Program

MDSAP (Medical Device Single Control Program) is one of the (very) few harmonization programs…

EU MDR – IVDR

Determining the Medical Device Classification and related classification rule is the first step in the EU CE…

CE Product Certification

With the introduction of IVDR, it turned out that bringing IVD devices to the EU market has turned…

FDA Quality System Regulation

With our US FDA 510(k) Consulting service, we help you go through the entire process by thoroughly…

Validation

Process Validation is performed to ensure consistent delivery of quality products that meet predeter…

Biocompatibility – Biological Evaluation

A medical device is not expected to evoke any biological response in the patient when used as…

Clinical Evaluation

Clinical evaluation is required for medical devices under medical device directive 93/42/EEC…

Clinical Data Evaluation

What are the sources of documents and data used in Clinical Evaluation?

PMS & PMCF

Regardless of the classification of the medical device, Post-Market Inspection is necessary and…

SSCP

The Safety and Clinical Performance Summary is to provide healthcare professionals with…

GAP Analysis In Healthcare

Gone are the days when the family doctor made house calls. Welcome to the modern healthcare…

UTS and EUDAMED Records

Product Tracking System (ÜTS for short), MDR, EUDAMED are among the topics that the medical…

Training

Our training services for many of the subjects we provide consultancy services…

Your Regulatory Expert

With 20 years of experience in manufacturing, inspection and R&D in the medical device industry, we will help you develop your product in accordance with worldwide regulatory requirements.

MedENvolve Consultancy

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Koek
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COMMENTS

Customer Satisfaction

“

“ As Growthimports, we are excited to announce that we have signed a partnership agreement with MedEVvolve Consultancy. With over 15 years experience as a lead auditor for notified bodies in the medical device industry as well as being in charge of quality assurance for various medical device manufacturers, implementation of CE marking and ISO quality systems, MedENvolve auditors brings strong experience and regulatory expertise.
”
– Emre Aykaç, Growthimports, Holland
“ I would like to thank MedENvolve consulting company for guiding us and helping my team through the CE certification process. I hope we can continue this cooperation for many years. ”
– Sertaç Karpat, HipKnee
20+years of experience
240+Satisfied Customers
2000+Successful Projects
25+Company Consultancy

DO YOU HAVE A QUESTION?

Frequently Asked Questions

1) EU MDR’ye ne zaman hazırlanmaya başlamalıyım?

Medenvolve Consultancy2023-12-05T21:46:57+03:00İki yıl önce yeni yönetmeliğin yayımlanacağı duyurusu ilk yapıldığında. Yardıma ihtiyacınız olduğu için bugün 05447772038 numaralı telefondan bizi arayın.

1) When should I start preparing for the EU MDR?

Medenvolve Consultancy2023-12-07T19:02:06+03:00Two years ago when the announcement of the new regulation was first made. Call us today at 05447772038 if you need help.

2) Bu değişiklikler beni etkiler mi?

Medenvolve Consultancy2023-12-05T21:46:51+03:00

Cihazınızı Avrupa Birliği’nde (AB) MDD uyarınca pazarlıyorsanız, MDR kapsamında cihazların tarihsel tahsisinin olmadığını unutmayın. Ek olarak, cihaz sınıflandırmanız da değişmiş olabilir ve şimdi teknik dosyanın klinik değerlendirmesini ve yenilenmesini gerektirebilir.

2) Will these changes affect me?

Medenvolve Consultancy2023-12-07T19:02:37+03:00If you market your device in the European Union (EU) under the MDD, note that there is no historical allocation of devices under the MDR. In addition, your device classification may have changed and may now require clinical assessment and renewal of the technical dossier.

3) Ürünüm EU MDR’ye uymakla yükümlü mü?

Medenvolve Consultancy2023-12-05T21:46:39+03:00Yeni AB Tıbbi Cihaz Yönetmeliği, AB MDR uygulanabilirliğinin kapsamını genişletmiştir. Daha önce tıbbi cihaz olarak kabul edilmeyen bazı ürünler, artık tıbbi cihaz yönetmeliği kapsamındadır. Yeni eklenen ürünler şunları içerir:

Göze veya göze sokulması amaçlanan kontakt lensler veya diğer maddeler.
Dövme ürünleri ve piercingler hariç vücut parçalarının anatomisini veya fiksasyonunu değiştirmek amacıyla cerrahi olarak invaziv yollarla tamamen veya kısmen insan vücuduna sokulması amaçlanan ürünler.
Dövme için olanlar hariç, deri altı, submukoza veya intradermal enjeksiyon veya diğer girişlerle yüz veya diğer dermal veya mukoza zarının doldurulması için kullanılması amaçlanan maddeler, madde kombinasyonları veya öğeler.
Liposuction, lipoliz veya lipoplasti için ekipman gibi yağ dokusunu azaltmak, çıkarmak veya yok etmek için kullanılması amaçlanan ekipman.
Tutarlı ve uyumlu olmayan kaynaklar, lazerler ve yoğun darbeli ışık ekipmanı gibi monokromatik ve geniş spektrum dahil olmak üzere insan vücudunda kullanılması amaçlanan yüksek yoğunluklu elektromanyetik radyasyon (örneğin kızıl ötesi, görünür ışık ve ultraviyole) yayan ekipman. cilt yenileme, dövme veya epilasyon veya diğer cilt tedavisi.
Beyindeki nöronal aktiviteyi değiştirmek için kafata

3) Is my product obliged to comply with the EU MDR?

Medenvolve Consultancy2023-12-07T19:03:39+03:00The new EU Medical Device Regulation has broadened the scope of EU MDR applicability. Some products that were not previously recognized as medical devices are now covered by the medical device regulation. The newly added products include:

Contact lenses or other substances intended to be inserted into or on the eye.
Products intended to be inserted, in whole or in part, into the human body by surgically invasive means for the purpose of altering the anatomy or fixation of body parts, except for tattoo products and piercings.
Substances, combinations of substances or items intended for use for filling the face or other dermal or mucous membranes by subcutaneous, submucosal or intradermal injection or other introduction, except for tattooing.
Equipment intended for use to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
Equipment that emits high-intensity electromagnetic radiation (e.g. infrared, visible light and ultraviolet) intended for use on the human body, including monochromatic and broad spectrum, such as coherent and incoherent sources, lasers and intense pulsed light equipment for skin resurfacing, tattooing or hair removal or other skin treatment.
The skull to alter neuronal activity in the brain.

4) Şimdi atmam gereken ilk adım nedir?

Medenvolve Consultancy2023-12-05T21:45:32+03:00

AB’nin herhangi bir tıbbi cihaz üreticisi için büyük bir pazar olduğunu ve bu geliri kaybetmenin işiniz üzerinde olumsuz bir etkisi olacağını biliyoruz. Mevcut kalite sisteminizin ve dokümantasyonunuzun boşluk analizini yaparak başlamanızı öneririz. Aşağıdaki formu kullanarak hemen bizimle iletişime geçin. AB MDR uzmanlarından oluşan ekibimiz, sonraki adımlarınızı planlamanıza yardımcı olacaktır.

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Are You Ready for MDR – IVDR Process?

As of May 26, 2021, the European Union is implementing stricter rules on Medical Devices (MDR). From May 26, 2022, the new regulations will also apply to In Vitro Diagnostic (IVDR) Regulations. Find out what the consequences are for you as a distributor or importer.